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A Study to Evaluate 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT02190721
First received: July 11, 2014
Last updated: April 25, 2017
Last verified: April 2017
  Purpose
The purpose of the study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of daily subcutaneous administration of 5 μg/kg tbo-filgrastim in infants, children and adolescents with solid tumors without bone marrow involvement.

Condition Intervention Phase
Solid Tumors Drug: tbo-filgrastim Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Efficacy, and Immunogenicity of Daily Subcutaneous Administration of 5 μg/kg Tbo-filgrastim in Infants, Children and Adolescents With Solid Tumors Without Bone Marrow Involvement

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Percentage of participants with Adverse Events [ Time Frame: 90 Days ]
    Safety will be assessed by evaluating adverse event reports throughout the study using descriptive statistics

  • Incidence of febrile neutropenia. [ Time Frame: 15 Days ]
    During cycle 1: The first dose of tbo-filgrastim will be administered after 24 hours (±3 hours) following the end of myelosuppressive chemotherapy (CTX) in week 1 of the study cycle 1.


Secondary Outcome Measures:
  • Change from Baseline in blood lab results [ Time Frame: Day 1 and 21 ]
    clinical laboratory test results at screening and at the end-of-study visit

  • Change from Baseline in Vital Signs [ Time Frame: 21 Days ]
    vital sign measurements at screening, throughout the study treatment, and at the end-of-study visit

  • Electrocardiography (ECG) findings [ Time Frame: Day 1, 4 & 6 hours post dose, Day 21 ]
  • Concomitant medication usage [ Time Frame: 90 Days ]
    Any concomitant medication usage throughout the study

  • Spleen sonography [ Time Frame: Day 1, 4, and 21 ]
  • Local tolerability at the injection site [ Time Frame: 1 hour (±30 minutes) after each study drug injection ]
  • Anti-drug antibody assessment [ Time Frame: Day 1, 21, and 90 ]
  • Overall Survival [ Time Frame: 90 Days ]
  • Maximum observed plasma/serum drug concentration (Cmax) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration

  • Time to maximum observed drug concentration (tmax) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration

  • area under the serum drug concentration (AUC0-12) [ Time Frame: 12 hours ]
    area under the serum drug concentration by time curve from time 0 to 12 hours postdose (AUC0-12) Up to 12 Hours from Filgrastim administration

  • Area under the serum concentration (AUC0-∞) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration

  • Elimination half-life (t½) [ Time Frame: 12 Hours ]
    Up to 12 Hours from Filgrastim administration

  • Incidence and duration of severe neutropenia (DSN, ANC <0.5 × 109/L) [ Time Frame: Day 15 ]
    During Cycle 1

  • Area under the curve of absolute neutrophil count (AUCANC) [ Time Frame: Day 15 ]
    During Cycle 1

  • ANC nadir (measured in 109/L) [ Time Frame: Day 15 ]
    During Cycle 1

  • Time to ANC nadir [ Time Frame: Day 15 ]
    During Cycle 1

  • Time to ANC recovery to ≥1.0 × 109/L [ Time Frame: Day 15 ]
    During Cycle 1

  • Time to ANC recovery to ≥2.0 × 109/ [ Time Frame: Day 15 ]
    During Cycle 1


Enrollment: 50
Actual Study Start Date: May 31, 2015
Estimated Study Completion Date: May 31, 2017
Primary Completion Date: April 4, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tbo-filgrastim
Patients will receive subcutaneous doses of tbo-filgrastim 5 μg/kg body weight daily; each daily dose, to be administered at the investigative site
Drug: tbo-filgrastim
5 μg/kg

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Male or female infants, children and adolescents aged 1 month to <16 years.
  2. Patients with solid tumors without bone marrow involvement, who are scheduled to receive myelosuppressive CTX.
  3. Body weight ≥5 kg.
  4. Patients must have an initial diagnosis and histologic proof of their malignancy. All enrolled subjects should have signed consent for a CTX regimen that is known to be myelotoxic, with counts expected to drop below the absolute neutrophil count (ANC) of 0.5 × 109/L for at least 3 days. These regimens would include at least one of the following:

    • Etoposide
    • doxorubicin
    • ifosfamide
    • cyclophosphamide
  5. ANC and platelet count: Patients must have an ANC >1 × 109/L and a platelet count >100 × 109/L to be eligible for therapy at the start of CTX.
  6. Normal cardiac, renal, and hepatic function.
  7. All subjects must have a life expectancy of 12 weeks or more.
  8. Performance Status: Lansky performance score >60 (age 1 to <16 years).

    • More criteria may apply, please contact the investigator for more information.

Exclusion:

  1. Bone marrow involvement.
  2. Active myelogenous leukemia or history of myelogenous leukemia.
  3. Previous treatment with colony-stimulating factors (granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, interleukin 11 [IL-11]) less than 6 weeks prior to study entry.
  4. History of congenital neutropenia or cyclic neutropenia.
  5. Pregnant or nursing female patients.
  6. Fertile patients who do not agree to use highly reliable contraceptive measures Prior bone marrow or stem cell transplant, or prior radiation to ≥25% of bone marrow within the 4 weeks prior to the first tbo-filgrastim dose.
  7. Ongoing active infection or history of infectious disease within 2 weeks prior to the screening visit.
  8. Treatment with lithium at screening or planned during the study

    • More criteria may apply, please contact the investigator for more information.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02190721

Locations
United States, California
Teva Investigational Site 12951
Los Angeles, California, United States
United States, New York
Teva Investigational Site 12959
Valhalla, New York, United States
Croatia
Teva Investigational Site 60015
Rijeka, Croatia
Teva Investigational Site 60014
Zagreb, Croatia
Teva Investigational Site 60016
Zagreb, Croatia
Hungary
Teva Investigational Site 51185
Budapest, Hungary
Teva Investigational Site 51186
Budapest, Hungary
Teva Investigational Site 51184
Szeged, Hungary
Poland
Teva Investigational Site 53249
Gdansk, Poland
Teva Investigational Site 53248
Lublin, Poland
Teva Investigational Site 53245
Warszawa, Poland
Teva Investigational Site 53246
Warszawa, Poland
Romania
Teva Investigational Site 52063
Bucharest, Romania
Teva Investigational Site 52064
Cluj-Napoca, Cluj, Romania
Russian Federation
Teva Investigational Site 50282
Chelyabinsk, Russian Federation
Teva Investigational Site 50281
Krasnodar, Russian Federation
Teva Investigational Site 50284
Moscow, Russian Federation
Teva Investigational Site 50280
St. Petersburg, Russian Federation
Teva Investigational Site 50283
Volgograd, Russian Federation
Ukraine
Teva Investigational Site 58147
Kharkiv, Ukraine
Teva Investigational Site 58145
Kyiv, Ukraine
Teva Investigational Site 58148
Lviv, Ukraine
Sponsors and Collaborators
Teva Pharmaceutical Industries
Investigators
Study Director: Teva Medical Expert, MD TEVA
  More Information

Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT02190721     History of Changes
Other Study ID Numbers: XM02-ONC-201
2014-001772-55 ( EudraCT Number )
Study First Received: July 11, 2014
Last Updated: April 25, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Teva Pharmaceutical Industries:
Neutropenia

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017